Trial Innovation Network

  • Key organizational components include the TICs, RIC, and CTSA Program Hubs
  •  All are key partners of the Trial Innovation Network and make unique and essential contributions
  • Other important partners include NIH Institutes, other federal and non-federal stakeholders, researchers, patients, providers, and the public

Trial Innovation Centers (TICs)

  • Innovation Centers focused on operational excellence, operational innovation, and quality by design
  • The TICs are charged with coordinating and providing innovative, high quality operational support for clinical trials.
  • TICs – Duke University/Vanderbilt University; University of Utah; Johns Hopkins University/Tufts University

Recruitment Innovation Center (RIC)

  • Innovation Center focused on innovative and evidence-based approaches to participant recruitment, retention, and engagement
  • The RIC will provide tools and services to enhance participant recruitment and retention
  • RIC – Vanderbilt University with partners at Columbia University, the Ohio State University, Rockefeller University, and the University of Utah

Trial Innovation Network Hub Liaison Teams

  • Frontline of the Trial Innovation Network. The Trial Innovation Network Hub Liaison Teams (formerly referred to as TIC Liaisons and RIC Liaisons) will lead the Network at the local level and will connect the Hubs to the TICs and RIC.
  • Trial Innovation Network Hub Liaison Teams will use their experience and knowledge of the local environment to coordinate Trial Innovation activities at their Institutions, tailoring general Network plans into more specific action plans that are best suited for their Hubs.
  • The Trial Innovation Network Hub Liaison Teams will work with the TICs and RIC to operationalize Network Projects.
  • Potential initial members of a Trial Innovation Network Hub Liaison Team might include a Medical Director (an experienced clinical investigator knowledgeable about clinical trials and the local environment) who would lead the team, and experienced clinical research staff with expertise in IRBs, contracts, and informatics.

Network Executive Committee (NEC)

  • Includes PI representatives from the TICs and RIC and NCATS.  The NEC also includes 3 individuals who act as TIC PIs and CTSA Program Hub PIs. The NEC is accountable for collective executive decisions for the Trial Innovation Network and provides regular updates to the CTSA Program. The NEC is advisory to NCATS.
  • The NEC is responsible for collaborative strategic planning and day to day management of the Trial Innovation Network. The NEC responsibilities include developing and implementing the vision, goals, and strategic plan (including the operational scientific strategic priorities) of the Trial Innovation Network, collaboratively engaging stakeholders, and ensuring excellence and harmonization across the Trial Innovation Network
  • The NEC has committed to fostering an environment of teamwork, collaboration, and productivity by proactively communicating across the Trial Innovation Network and CTSA Program, working together on the common goals and shared vision of the Trial Innovation Network, and focusing on results, operational excellence, and operational innovation.

Trial Innovation Network Work Groups 

Work Group Charge of Work Group
Administration and Organization
  • Organize & harmonize administrative issues of Network
  • Develop Network Manual of Operations
  • Work with website team to develop shared workspace
  • Develop communication strategy and manage day to day communication with Network Hub Liaison Teams
  • Present updates and key recommendations to NEC for review & approval, provide content updates for website
Central IRB System
  • Organize & harmonize cIRB system across Network
  • Harmonize cIRB SOPs with other
  • Create framework for local workflows for cIRB
  • Develop performance metrics for cIRB
  • Present updates and key recommendations to NEC for review & approval, provide content updates for website
Engaging Patients/Providers/Public
  • Develop strategies to engage Hubs (specifically Community Engagement & IT Cores) & leverage resources/expertise
  • Present updates and key recommendations to NEC for review & approval, provide content updates for website
Operational Scientific Priorities/Metrics (on hold)
  • Identify operational scientific priorities and innovation priorities
  • Identify key metrics related to scientific priorities, innovation, and process
Organization, Governance, & Communication
  • Discuss executive level issues related to Network
  • Develop plans for governance
Proposal Assessment Team
  • Assess Network Project Proposals for potential for operational innovation, feasibility, and alignment with capacity and stage of Network
  • Make assignments to TICs and RIC
Standard Agreements and Streamlined Budgeting
  • Organize & harmonize Standard Contract efforts across Network
  • Develop & implement approaches for streamlined budgeting
  • Create framework for local workflows for Standard Contracts
  • Develop performance metrics for Standard Contracts
  • Present updates and key recommendations to NEC for review & approval, provide content updates for website
Trial Innovation Network Team Meetings
  • Includes TICs, RIC, NCATS (2-3 members each) and 2 members from Trial Innovation Network Hub Liaison Teams
  • Share information from TICs/RIC/NCATS
  • Share information from Hubs
  • Learn best practices
  • Opportunity to hear about issues arising at Hubs
Website and Communications
  • Develop Trial Innovation Network Website (updates from NEC, WGs, and other aspects of Network)
  • Coordinate intake portal for proposals
  • Develop pages for updates on Network Projects/Trials/Studies
  • Work with Admin/Organ. WG on content for workspace, research pages
  • Create Open Innovation pages and publicly available content
  • Present key updates and recommendations to NEC for review & approval, review an finalize content updates for website